Presently, evaluation of blood by self-monitoring blood glucose (SMBG) devices is a predominant method for the detection of diabetes. SMBG is recognized by the American Diabetes Association as an important part of effective diabetes self-management. The American Diabetes Association recommends that the patients on multiple-dose insulin or insulin pump therapy should perform SMBG prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving. This translates to SMBG device use frequency of 6 to 10 times per day.
Current at-home tests (e.g., A1C tests and home pregnancy tests, and monitors for blood glucose, blood pressure and heart rate, and blood cholesterol level) while typically quick, are largely “unconnected” and most are invasive. Only some glucose monitors and breathalyzers provide connections and trending. In addition, at-home tests are typically targeted toward very specific conditions and generally do not enable a broader opportunity for detection and monitoring multiple diseases. In the breath monitoring segment, there are a number of technologies being used, or under development, which do not meet standards necessary for home-based sampling. For example, such technologies can include GC-MS, mini-GC-MS, real-time MS (SIFT, PTR/PTR-ToF, IMS), e-nose, MEMs, diode laser spectroscopy, and mid-IR laser spectroscopy. In general, to be appropriate for home monitoring, a product should have a reasonable cost, be accurate and durable, provide fast real-time results, be portable and allow easy self-administration. Each of the noted technologies has different technical hurdles and/or advantages/disadvantages.
For example, e-nose technology, which recognizes patterns, shows promise but generally has not demonstrated the level of sensitivity and accuracy necessary for pinpointing sub-ppm levels of specific compounds. Several breath tests have received FDA approval, including testing for airway inflammation, H. pylori, heart transplant rejection, alcohol, and CO2 poisoning. In general, each addresses only one condition and mobile breath sensors manufacturing technologies do not provide desired sensitivity and response times. There are a number of new entrants who are seeking to provide clinical-grade information for the home monitoring market addressing multiple conditions. Focus has typically been on indicators such as blood pressure, pulse, temperature, ECG and blood oxygen levels.
Thus, an interest exists for improved sensor assemblies, and related methods of use. These and other inefficiencies and opportunities for improvement are addressed and/or overcome by the assemblies, systems and methods of the present disclosure.